Original article
Clinical endoscopy
Open-label, sham-controlled trial of an endoscopic duodenojejunal bypass liner for preoperative weight loss in bariatric surgery candidates

https://doi.org/10.1016/j.gie.2009.11.051Get rights and content

Background

The duodenojejunal bypass liner (DJBL) (EndoBarrier Gastrointestinal Liner) is an endoscopically placed and removable intestinal liner that creates a duodenojejunal bypass resulting in weight loss and improvement in type 2 diabetes mellitus.

Objective

Weight loss before bariatric surgery to decrease perioperative complications.

Design

Prospective, randomized, sham-controlled trial.

Setting

Multicenter, tertiary care, teaching hospitals.

Patients

Twenty-one obese subjects in the DJBL arm and 26 obese subjects in the sham arm composed the intent-to-treat population.

Interventions

The subjects in the sham arm underwent an EGD and mock implantation. Both groups received identical nutritional counseling.

Main Outcome Measurements

The primary endpoint was the difference in the percentage of excess weight loss (EWL) at week 12 between the 2 groups. Secondary endpoints were the percentage of subjects achieving 10% EWL, total weight change, and device safety.

Results

Thirteen DJBL arm subjects and 24 sham arm subjects completed the 12-week study. EWL was 11.9% ± 1.4% and 2.7% ± 2.0% for the DJBL and sham arms, respectively (P < .05). In the DJBL arm, 62% achieved 10% or more EWL compared with 17% of the subjects in the sham arm (P < .05). Total weight change in the DJBL arm was −8.2 ± 1.3 kg compared with −2.1 ± 1.1 kg in the sham arm (P < .05). Eight DJBL subjects terminated early because of GI bleeding (n = 3), abdominal pain (n = 2), nausea and vomiting (n = 2), and an unrelated preexisting illness (n = 1). None had further clinical symptoms after DJBL explantation.

Limitations

Study personnel were not blinded. There was a lack of data on caloric intake.

Conclusions

The DJBL achieved endoscopic duodenal exclusion and promoted significant weight loss beyond a minimal sham effect in candidates for bariatric surgery. (Clinical trial registration number: NPT00469391.)

Section snippets

Mechanisms of weight loss

RYGB and BPD reroute chyme such that the duodenum and proximal jejunum are bypassed, promoting chyme delivery directly to the jejunum.5 In an effort to treat obese patients less invasively, nonsurgical endoluminal procedures have been attempted with variable success.13, 14 Many share the ability to reduce gastric volume, thereby restricting the passage of food through the stomach into the duodenum. An alternative approach would be to duplicate the effects of the gastric bypass/BPD by diverting

Study population

This 12-week, open-label, randomized trial investigated the use of the DJBL versus a sham upper endoscopy for weight loss before bariatric surgery. It was conducted from May 2007 to November 2008 at 4 sites in the United States in accordance with Good Clinical Practice and in compliance with each institution's Investigational Review Board.

Subjects were people 18 years of age or older and 55 years of age or younger in whom nonsurgical weight loss treatments failed. The baseline BMI was 40 kg/m2

Study population

Sixty-nine subjects were screened, with 58 meeting all inclusion and no exclusion criteria (Fig. 3). Two subjects withdrew before randomization at their request. Twenty-seven subjects were randomized to the DJBL arm and 29 to the sham arm. Two subjects initially randomized to the DJBL arm were removed before implantation at their request. In the sham arm, 2 subjects were discontinued at their request, and a third was lost to follow-up. Therefore, 25 subjects randomized to the DJBL arm underwent

Discussion

This 12-week trial evaluated the safety and weight loss efficacy of the DJBL as adjunctive therapy before bariatric surgery. Subjects who tolerated the DJBL experienced significantly greater weight loss than sham subjects, even though both groups received the same preoperative nutritional counseling.

There is a growing acceptance among clinicians that preoperative weight loss is beneficial for those undergoing bariatric surgery.9, 10, 11, 12, 18, 19, 20 The 1998 National Institutes of Health

Conclusions

The DJBL can be safely implanted and explanted endoscopically and maintained for 12 weeks. Importantly, the DJBL achieved significant preoperative weight loss compared with standard counseling in candidates for bariatric surgery. These data support further clinical research with the DJBL in obese subjects.

Acknowledgments

The authors thank Andy Levine, Ken Malomo, and Aurora Liao, PhD, for data analysis and assistance in the conduct of the study, and Loretta L. Nielsen, PhD, for medical writing.

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    DISCLOSURE: The following author disclosed financial relationships relevant to this publication: K.S. Gersin: Consultant to and shareholder in GI Dynamics. All other authors disclosed no financial relationships relevant to this publication. This work was supported by funding from GI Dynamics, Inc.

    See CME section; p. 1028

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